Quality Assurance
Our Commitment to Quality
cGMP manufacturing requires ensuring proper identity, strength, purity, and quality of each dose that may be used by a patient or given to a clinical study participant.
Adhering to Quality by Design (QbD) principles, Vici designs formulations which upholds pre-set quality standards.
Quality is assured through careful, SOP-based control of raw materials supply chain, employee training, facility maintenance, equipment qualification, regular maintenance and calibration, formulation and test method development, batch manufacturing, release testing, and documentation.
Vici’s analytical testing lab develops, validates, and performs release testing on clinical supply material to issue a Certificate of Analysis (CoA).
Our analytical lab is governed by a strict SOP-driven quality system. All of our equipment undergoes routine preventive maintenance and calibration. Our HPLCs are 21 CFR Part 11 compliant. Vici follows good documentation practices and staff are trained on all SOPs. The lab system is overseen by the Quality Assurance (QA) group.
Vici operates four purpose-built formulation suites with state-of-the-art equipment for GMP batch manufacturing.